FDA Approves Istodax for Peripheral T-Cell Lymphoma

SUMMIT, N.J.--(BUSINESS WIRE)--Jun 17, 2011 - Celgene
Corporation today announced that the U.S. Food and
Drug Administration (FDA) has granted accelerated approval for its
Supplemental New Drug Application (sNDA) for an additional
indication for Istodax (romidepsin) for injection for the treatment
of peripheral T-cell lymphoma (PTCL) in patients who have received
at least one prior therapy. Istodax is also approved for the
treatment of cutaneous T-cell lymphoma (CTCL) in patients who have
received at least one prior systemic therapy. These indications are
based on response rate. Clinical benefit such as improvement in
overall survival has not been demonstrated.

The PTCL approval was based on a priority (6 month) review by
the FDA. Priority reviews are reserved for serious and
life-threatening conditions that have an unmet medical need.

The Istodax sNDA approval is based upon results from two
studies, a Phase II, multicenter, international, open-label,
single-arm study of Istodax in patients with PTCL who had failed at
least one prior systemic therapy (Study 3), which was presented at
the 2010 American Society of Hematology annual meeting, and a
single-arm clinical study of Istodax in patients with PTCL who had
failed prior therapy (Study 4).

About Istodax

Istodax (romidepsin) for injection is an
epigenetic therapy and a member of a class of cancer drugs known as
histone deacetylase (HDAC) inhibitors. HDACs catalyze the removal
of acetyl groups from acetylated lysine residues in histones,
resulting in the modulation of gene expression. HDACs also
deacetylate non-histone proteins, such as transcription factors. In
vitro, Istodax causes the accumulation of acetylated histones, and
induces cell cycle arrest and apoptosis of some cancer cell lines.
The mechanism of the antineoplastic effect of romidepsin observed
in nonclinical and clinical studies has not been fully
characterized. For full prescribing information, visit www.istodax.com.

Istodax (romidepsin) for injection is indicated for
treatment of cutaneous T-cell lymphoma (CTCL) in patients who have
received at least one prior systemic therapy.

Istodax (romidepsin) for injection is indicated for
treatment of peripheral T-cell lymphoma (PTCL) in patients who have
received at least one prior therapy.

These indications are based on response rate. Clinical benefit
such as improvement in overall survival has not been
demonstrated.

Important Safety Information

WARNINGS AND PRECAUTIONS:

Treatment with Istodax has been
associated with thrombocytopenia, leukopenia (neutropenia and
lymphopenia), and anemia; therefore, monitor these hematological
parameters during treatment with Istodax and modify the dose as
necessary

Serious and sometimes fatal infections
have been reported during treatment and within 30 days after
treatment with Istodax and the risk of life threatening infections
may be higher in patients with a history of extensive or intensive
chemotherapy.

Electrocardiographic (ECG) changes have
been observed with Istodax

In patients with congenital long QT
syndrome, a history of significant cardiovascular disease, and
patients taking anti-arrhythmic medicines or medicinal products
that lead to significant QT prolongation, appropriate
cardiovascular monitoring precautions should be considered, such as
monitoring electrolytes and ECGs at baseline and periodically
during treatment

Due to the risk of QT prolongation,
ensure that potassium and magnesium are within the normal range
before administration

Tumor lysis syndrome has been reported
during treatment with Istodax. Patients with advanced stage disease
and/or high tumor burden should be closely monitored and
appropriate precautions taken, and treatment should be instituted
as appropriate

Based on its mechanism of action,
Istodax may cause fetal harm when administered to a pregnant woman.
If this drug is used during pregnancy, or if the patient becomes
pregnant while taking Istodax, the patient should be apprised of
the potential hazard to the fetus (Pregnancy Category D)

Istodax binds to estrogen receptors.
Advise women of childbearing potential that Istodax may reduce the
effectiveness of estrogen-containing contraceptives

Infections were the most common type of
serious adverse event reported in both Study 1 (n=102) and Study 2
(n=83) with 8 patients (8%) in Study 1 and 26 patients (31%) in
Study 2 experiencing a serious infection.

Because many drugs are excreted in
human milk and because of the potential for serious adverse
reactions in nursing infants from Istodax, a decision should be
made whether to discontinue nursing or discontinue the drug, taking
into account the importance of the drug to the mother

Patients with moderate and severe
hepatic impairment and/or patients with end-stage renal disease
should be treated with caution

Please see full Prescribing Information, including WARNINGS
AND PRECAUTIONS and ADVERSE REACTIONS.

Istodax (romidepsin) for injection is indicated for
treatment of peripheral T-cell lymphoma (PTCL) in patients who have
received at least one prior therapy. This indication is based on
response rate. Clinical benefit such as improvement in overall
survival has not been demonstrated.

About PTCL

Peripheral T-cell lymphoma comprises a heterogeneous group of
malignancies of T-cell origin that account for about 10-15% of all
cases of non-Hodgkin's lymphoma. PTCL can occur from young
adulthood to old age and is slightly more common in men than in
women. It is a particularly aggressive form of lymphoma with a
short median duration of survival (approximately two years) from
diagnosis.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in
the discovery, development and commercialization of novel therapies
for the treatment of cancer and inflammatory diseases through gene
and protein regulation. For more information, please visit the
company's Web site at
www.celgene.com.

This release contains certain forward-looking statements
which involve known and unknown risks, delays, uncertainties and
other factors not under the Company's control, which may cause
actual results, performance or achievements of the Company to be
materially different from the results, performance or other
expectations implied by these forward-looking statements. These
factors include results of current or pending research and
development activities, actions by the FDA and other regulatory
authorities, and those factors detailed in the Company's filings
with the Securities and Exchange Commission such as 10K, 10Q and 8K
reports.

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